OECD Principles of GLP

Objective

Preclinical studies are undertaken to identify a lead candidate and to select the best formulation; determine the route, frequency, and duration of exposure; and support clinical trial design. This course provides essential information on the OECD Principles of GLP, test guidelines and requirements by various regulatory authorities while conducting Preclinical studies.

Syllabus

The syllabus includes History and OECD Principles of GLP, GLP Consensus Documents, Guidance Documents for Compliance Monitoring Authorities, Advisory Documents of the Working Group on GLP, Position Papers, Regulatory authorities, Introduction to Toxicology, Toxicology studies, Ecotoxicology studies, Genetic Toxicology studies, Developmental & Reproductive Toxicology studies, OECD test guidelines and Biocompatibility studies.